Country of Origin Regulations 2020 for Listed and Registered Medicines
The Competition and Consumer Amendment (Australian Consumer Law – Country of Origin Representations) Regulations 2020 passed on 10 December 2020 providing stronger protections for the complementary medicines industry by strengthening Country of Origin laws.
It remains voluntary for the complementary medicines sector to make Australian origin claims under the safe harbour provisions and the above regulations. However, the regulations now prescribe, by law, a process of substantial transformation. This process in the regulations gives circumstances that may be relied upon when making a voluntary Australian Made or Made in Australia, Country of Origin claim on a complementary medicine. These new regulations ensure that these claims can be made without potentially breaching the regulations within the Competition and Consumer Regulations 2010.
Under the Regulations, for a complementary medicine to rely on the safe harbour provisions:
- it must have undergone substantial transformation in Australia. That is, the last dosage form step of manufacture must be performed in Australia, excluding packing and labelling;
- in addition, these steps must be authorised by license to occur at the premises where the step takes place, i.e. at the TGA GMP approved premises listed as the manufacturer of the finished product dosage form on the ARTG.
The above regulations strengthen protection from a legal and global perspective to sponsors making the Australian Made or Made in Australia claims, however there is no technical change required to the approach that has been taken under the existing safe harbour laws and the introduction of 92AA of the regulations in December 2019.
Further changes
Sponsors should be aware that the consultation for the Information Standard is still under Government consideration and may result in further changes in 2021.
